Clinical trial agreement - Eliminate legal problems when conducting clinical trials in Germany

The possibilities of structuring clinical trial agreement are far reaching. Especially regarding the question, who the contract partner will be, an initial, also liability-related, positioning is possible; by either including or not including the respective examining physician in the agreement. The agreement has in large parts a clarifying function regarding the contractual obligations of both parties, as the AMG, the ICH-GCP guideline and various european regulations and directives stipulate a wide range of requirements for the performance of clinical trials. Inclusion in the agreement allows for a clear division of responsibilities and liability in the event of non-compliance with the requirements. It is also necessary that the sponsor is obligated to carry out quality assurance measures and the modalities of their implementation, including the remuneration of the time spent for this purpose.

A central question is also, who is entitled to the results of the clinical trial or to inventions based on them, whereby the Arbn Erf G also must be taken into account. Whether there are at least rights of use for non-commercial purposes for the other party, should also be regulated. Also relevant is the agreement of confidentiality agreements and the answer to the question, when and to which extent publications on the results of the tests in question are permissible, in order to ensure an appropriate balance of the parties’ interests.

In terms of data protection law, special attention must be paid to the question which party is the controller within the meaning of the GDPR - depending on the answer to this question, complicated and extensive regulations must be made. In addition to the regulation of the remuneration and its payment modalities, regulations regarding the liability, at least within the legal ramifications are possible and necessary. Conclusively - as always - general cancellation rights and other possibilities of terminating the agreement can be added.

The preceding explanations show how complex and comprehensive the aspects to be taken into account are. Numerous possibilities have been highlighted above, in order to provide an overview and to simplify the drafting, in hope that the contribution may aid as an orientation.